Trial Outcomes & Findings for Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients (NCT NCT01619982)
NCT ID: NCT01619982
Last Updated: 2018-05-16
Results Overview
Number of patients who receive preoperative vancomycin and cefazolin who develop a surgical site infection (SSI) compared to those whose received only cefazolin. Surveillance was done with standard procedures and definitions.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
Patients will be monitored for superficial SSIs for 30 days from the date of surgery. Patients will be monitored for 30 days for deep SSIs if no foreign material was implanted and for 1 year if foreign material is present.
Results posted on
2018-05-16
Participant Flow
Participant milestones
| Measure |
Cefazolin 25 mg/kg Body Weight and Vancomycin
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age.
|
Cefazolin 30 mg/kg Body Weight
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
12
|
|
Overall Study
COMPLETED
|
20
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
Baseline characteristics by cohort
| Measure |
Cefazolin 25 mg/kg Body Weight and Vancomycin
n=20 Participants
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age.
|
Cefazolin 30 mg/kg Body Weight
n=12 Participants
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
0 day to 12 months
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be monitored for superficial SSIs for 30 days from the date of surgery. Patients will be monitored for 30 days for deep SSIs if no foreign material was implanted and for 1 year if foreign material is present.Population: Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients undergoing cardiopulmonary bypass
Number of patients who receive preoperative vancomycin and cefazolin who develop a surgical site infection (SSI) compared to those whose received only cefazolin. Surveillance was done with standard procedures and definitions.
Outcome measures
| Measure |
Cefazolin 25mg/kg Body Weight and Vancomycin
n=20 Participants
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.
|
Cefazolin 30mg/kg Body Weight
n=12 Participants
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Number of Patients Who Receive Preoperative Vancomycin and Cefazolin Who Develop a Surgical Site Infection Compared to Those Whose Received Only Cefazolin.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)Population: Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group
Cefazolin Pharmacokinetics was measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)
Outcome measures
| Measure |
Cefazolin 25mg/kg Body Weight and Vancomycin
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.
|
Cefazolin 30mg/kg Body Weight
n=10 Participants
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Cefazolin Pharmacokinetics
Peripheral Volume (Fast)
|
—
|
0.102 L
Interval 0.099 to 0.103
|
|
Cefazolin Pharmacokinetics
Peripheral Volume (slow)
|
—
|
0.7 L
Interval 0.69 to 0.71
|
|
Cefazolin Pharmacokinetics
Central Volume
|
—
|
0.547 L
Interval 0.408 to 0.685
|
SECONDARY outcome
Timeframe: Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)Population: Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group
Measured as Elimination Clearance Inter-tissue Clearance (Fast) Inter-tissue Clearance(Slow)
Outcome measures
| Measure |
Cefazolin 25mg/kg Body Weight and Vancomycin
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.
|
Cefazolin 30mg/kg Body Weight
n=10 Participants
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Cefazolin Pharmacokinetics
Elimination clearance
|
—
|
0.00396 L/min
Interval 0.00393 to 0.00398
|
|
Cefazolin Pharmacokinetics
Inter-tissue Clearance (Fast)
|
—
|
0.1 L/min
Interval 0.1 to 0.102
|
|
Cefazolin Pharmacokinetics
Inter-tissue Clearance (slow)
|
—
|
0.0231 L/min
Interval 0.023 to 0.0232
|
SECONDARY outcome
Timeframe: Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)Population: Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm
Vancomycin pharmacokinetics measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)
Outcome measures
| Measure |
Cefazolin 25mg/kg Body Weight and Vancomycin
n=10 Participants
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.
|
Cefazolin 30mg/kg Body Weight
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children During the Peri-operative Period in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Central Volume
|
0.901 L
Interval 0.79 to 1.07
|
—
|
|
Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children During the Peri-operative Period in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Peripheral Volume (Fast)
|
1.02 L
Interval 1.0 to 1.03
|
—
|
|
Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children During the Peri-operative Period in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Peripheral Volume (Slow)
|
1.81 L
Interval 1.8 to 1.83
|
—
|
SECONDARY outcome
Timeframe: Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)Population: Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm
Vancomycin pharmacokinetics measured as Elimination Clearance, Inter-tissue Clearance (Fast), Inter-tissue Clearance (Slow).
Outcome measures
| Measure |
Cefazolin 25mg/kg Body Weight and Vancomycin
n=10 Participants
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.
|
Cefazolin 30mg/kg Body Weight
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children on Cardiopulmonary Bypass (CPB)
Elimination Clearance
|
0.00695 L/min
Interval 0.0067 to 0.0071
|
—
|
|
Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children on Cardiopulmonary Bypass (CPB)
Inter-tissue Clearance (Fast)
|
0.0554 L/min
Interval 0.039 to 0.067
|
—
|
|
Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children on Cardiopulmonary Bypass (CPB)
Inter-tissue Clearance (Slow)
|
0.0202 L/min
Interval 0.017 to 0.026
|
—
|
SECONDARY outcome
Timeframe: Adverse events to vancomycin will be assessed on each patient in the study during the time the patient is in the operating room (0-<24 hours)Population: Only the Cefazolin 25 mg/kg Body Weight and Vancomycin groups were assessed, the Cefazolin 30mg/kg body weight did not receive vancomycin
Will evaluate for vancomycin associated pre or intraoperative adverse events: 1. Hypotension requiring treatment 2. Rash, flushing or Red Man's syndrome 3. Other changes in vital signs (decrease in baseline 02 sat, increased heart or respiratory rate, elevated body temperature) felt to be associated with vancomycin administration 4. An event associated with vancomycin administration which results in delay in surgery
Outcome measures
| Measure |
Cefazolin 25mg/kg Body Weight and Vancomycin
n=20 Participants
Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.
|
Cefazolin 30mg/kg Body Weight
Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
|
|---|---|---|
|
Count of Participants Experiencing Adverse Events Commonly Associated With Peri-operative Vancomycin Prophylaxis
|
0 Participants
|
—
|
Adverse Events
Cefazolin 25 mg/kg Body Weight and Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cefazolin30 mg/kg Body Weight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place